BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Aortotomy System Lancet 3.3mm

    DI: 00634624175334 · Model: ALX33 · QUEST MEDICAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Aortotomy System Lancet 3.3mm
    Primary DI
    00634624175334
    Version / Model
    ALX33
    Company Name
    QUEST MEDICAL INC
    Labeler DUNS
    041810693
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-10
    Public Version
    3
    Public Version Date
    2021-01-22
    Public Version Status
    Update
    Public Device Record Key
    230794e2-2ad1-4763-bef6-3fca9dfeb98b

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DWS Instruments, Surgical, Cardiovascular

    GMDN Terms

    Code Name
    37445 Manual scalpel blade, single-use

    Identifiers

    Type ID
    Package 20634624175338
    Primary 00634624175334